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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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21 December 2021 |
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Main ID: |
EUCTR2006-004230-32-PL |
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Date of registration:
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05/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study
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Scientific title:
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EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study |
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Date of first enrolment:
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07/12/2007 |
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Target sample size:
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300 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004230-32 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Italy
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Poland
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria:
Pre-inclusion criteria at screening visit:
- male or female = 18 and = 70 years old;
- women of child-bearing potential using effective contraceptive methods;
- history and documented diagnosis of ulcerative colitis, dated from more than 3 months;
Rectal bleeding score = 1;
- Stable dosage of ongoing oral mesalazine therapy (maximum dosage 3.2 g/day) For patients under treatment with other oral medication containing 5 ASA maximum allowed dosage at study entry is: balsalazide (6.7 g/day), or olsalazine (2 g/day) or sulfasalazine (3 g/day) in the last 14 days;
- Able to understand and to follow the protocol;
- Having given written informed consent for study participation;
Inclusion criteria at randomization (end of run-in period)
- Endoscopic score = 1 in one or more colon segments;
- DAI score = 3 and < 10;
- Confirmation of rectal bleeding score = 1;
- Negative stool examination for infectious disease;
- Absence of concomitant medications since the screening visit (especially for non authorized treatments);
- Negative pregnancy test for women
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Exclusion criteria at screening:
- Women of childbearing potential not using adequate contraceptive methods;
- Pregnant women or breast-feeding women;
- Severe ulcerative colitis or toxic megacolon;
- Infectious Colitis;
- Ischemic Colitis;
- Colitis induced by drug or radiotherapy;
- Chron's disease;
- Major gastro-intestinal surgery other than appendectomy;
- Evolutive active peptic ulcer or medical history of peptic ulcer complications;
- Non compensated diabetes mellitus;
- Non controlled arterial hypertension (SBP = 160 mm Hg and or DBP = 100 mm Hg)
- Hyperthyroidism;
- Medical history of concomitant cancer or other disease which, according to Investgators' opinion could interfere with the evaluation of the test drug;
- Poorly controlled pulmonary infections (tubercolosis, active mycotic infections);
- Patients receiving oral or injectable corticosteroids (oral budesonide included) within 30 days from screening visit, rectal corticosteroids (suppositories, enema, foams), inhaled corticosteroids in the 14 days prior to screening visit;
- Change in the dose of oral Mesalazine treatment, in the 14 days prior the screening visit or at a dosage superior to 3.2 g/day or balsalazide (6.7 g/day), olsalazine (2 g/day), or sulfasalazine (3 g/day);
- Patients being treated with H2-receptor antagonists or proton pump inhibitor (PPIs) in the previous 2 weeks ;
- Use of immunomodulators or immunodepressants in the previous 3 months;
- Patients treated with TNF-alfa antagonists in the previous 6 months;
- Antibiotic treatment that cannot be stopped before randomization;
- History of drug or alcohol abuse;
- Patients who took part to another trial in the previous 3 months-
Exclusion criteria at randomization (end of run-in period)
- Severe ulcerative colitis (DAI > 10);
- Positive ova and parasitic stool examination;
- Ulcerative Colitis with endoscopic store < 1 or rectal bleeding score < 1;
- Ulcerative Colitis limited to the rectum;
- Chron's Disease;
- Significant hepatic impairment (AST or ALT twice the upper limit of normal range);
- Significant renal impairment (sreum creatinine > 1.5 mg/dL);
- Any abnormal laboratory test which could interfere with the protocol
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination
MedDRA version: 9.1
Level: LLT
Classification code 10045365
Term: Ulcerative colitis
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Intervention(s)
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Trade Name: Clipper
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Beclomethasone diproprionate
CAS Number: 5534-09-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use
Trade Name: Deltacortene
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: Deltacortene
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisone
CAS Number: 53-03-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
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Primary Outcome(s)
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Main Objective: The primary efficacy objective of the trial is to demonstrate that the response to the treatment, measured in terms of DAI after 4 weeks of treatment, is not inferior in BDP group, compared to the one detected in the Prednisone group. The primary safety objective is to demonstrate a better safety profile in terms of steroid toxicity and reduction of endogenous cortisol production of BDP treatment compared to Prednisone treatment after 4 weeks of treatment
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Primary end point(s): The primary variable will be the percentage of patients with clinical response, defined as a DAI score < 3 or reduced of at least 3 points for patients with a baseline DAI = 7 after 4 weeks of treatment with test drugs.
The secondary variables will be: percentage of patients with clinical response after 4 weeks of treatment without steroid-related adverse event (AEs), including cortisol levels < 5 mcg/dL (or< 150 nmol/L); percentage of patients with DAI score = 1 after 4 weeks of treatment; change in DAI total score after 4 weeks of treatment; change in endoscopic store after 4 weeks of treatment; change in CAI total score after 4 and 8 weeks of treatment; changes in CRP, ESR, after 4 and 8 weeks of treatment.
The primary safety variable will be the percentage of patients with adverse events related to steroidal treatment including morning serum cortisol < 5 mcg/dL (or < 150 nmol/L) during the second 4 weeks of treatment (after visit 4 to Visit 6); changes from baseline to visits after 4 and 8 weeks of treatment (from Visit 2 to 4).
The secondary varables will be: percentage of patients with adverse events related to steroid treatment including morning serum cortisol < 5 mcg/dL (or < 150 nmol/L) during the second 4 weeks of treatment (after Visit 4 to Visit 6); changes from baseline to visits 4 and 8 weeks of treatment in morning cortisol level; chnges from baseline to visits after 4 and 8 weeks of treatment in laboratory test parameters; change from baseline to visit 4 and 6 in vital signs; percentage of patients with adverse events related to steroid treatment including morning serum cortisol < 5 mcg/dL (or < 150 nmol/L) during the whole treatment period
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Secondary Objective: Evaluation of efficacy of the 2 treatments in terms of improvements of disease related symptoms, general condition and disease severity, measured at week 4 and week 8;
Evaluation of the overall safety profile of the two treatment regimens after 4 and 8 weeks of treatment.
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Secondary ID(s)
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CMA-0402-PR-0005
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 04/09/2007
Contact:
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